- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06335940
Admission for Respiratory Disease And VIdeo Regulation System (ARAVIS-PED)
Pediatric dyspnea is a major health problem, accounting for up to 27% of admissions to emergency departments in winter. It is estimated that a significant number (13%) of patients presenting to emergency departments are outpatients, at a time when emergency departments are having to cope with an ever-increasing flow of patients.
Proper referral of patients calling the SAMU Centre-15 takes on its full meaning in this context, but regulating paediatric calls is more difficult. Indeed, the regulating doctor is most often in contact with the parents, who describe what they see and pass on their concerns, and it is difficult to have direct contact with patients who are often very young. Obtaining objective criteria such as saturation and respiratory rate is also a real challenge.
To overcome the complexity of medical regulation, a number of tools and aids have been developed, including visio or video-regulation (regulation via the camera on the caller's smartphone).
This device has been evaluated in a number of situations, enabling it to take its place in the daily practice of many doctors, but there is very little data concerning pediatric visio-regulation, particularly with regard to dyspnea.
To the best of the investigator knowledge, there is no prospective study looking at the impact of Video-Regulation on the outcome of patients requiring the advice of SAMU Centre-15 for pediatric dyspnea.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Guillaume Debaty
- Phone Number: +33 0476634256
- Email: gdebaty@chu-grenoble.fr
Study Contact Backup
- Name: Johanna Boeuf
- Phone Number: +33 0476634256
- Email: jboeuf1@chu-grenoble.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients included in this study will be children strictly under 10 years of age whose parents have called the SAMU38 for respiratory difficulties.
Therefore, patients who received ambulatory medical advice (with or without instructions to consult a general practitioner within a defined period of time), who were referred to the emergency service by their own means or who benefited from a first-aid vector (fire department or private ambulance) will be included.
Description
Inclusion Criteria:
- Age strictly less than 10 years
- Applicant calling the SAMU38 for a child with dyspnea announced or presumed by the interrogation.
- Patients for whom no opposition from parents has been obtained.
- Patients affiliated to social security
Exclusion Criteria:
- Call to organize a secondary intervention (or Inter-Hospital Transfer (TIH/TIIH)).
- Unsuccessful call (hung up when the dispatcher took the call, without the possibility of medical regulation).
- Refusal to take charge on arrival of rescue vector
- Call-back for a patient with an initial call to SAMU38 < 48h
- Means engaged by the CTA or an ARM even before medical regulation.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
No videoregulation
An initial period of 40 days during which we leave the use of video-regulation to the discretion of the regulating physicians (emergency physicians or general practitioners) when they are faced with a call labelled by a medical regulation assistant (ARM) "Pediatric dyspnea in a child under 10 years of age" or when they themselves judge that the call falls into this category; as is the case in the current practice of the SAMU38.
|
|
Videoregulation
A 40-day period during which we will encourage regulating physicians to use video-regulation for every call concerning "pediatric dyspnea in a child aged < 10 years".
|
To encourage the use of video-regulation, several measures will be taken to reinforce its use as much as possible:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To determine in children under 10 years of age for whom a call to the SAMU38 for dyspnea is made, whether the use of Visio-Regulation reduces the percentage of emergency room admissions compared with standard telephone medical regulation.
Time Frame: 24 hours
|
Percentage of participants with computerized admission to pediatric emergency departments
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate whether the increased use of video-regulation is not associated with a higher rate of hospitalization in a conventional ward or intensive care unit
Time Frame: 24 hours
|
Number of patients admitted to hospital or intensive care/resuscitation after emergency admission within 24 hours of the call
|
24 hours
|
Evaluate whether the use of video-regulation has an impact on the dispatcher's referral decision between ambulatory medicine and the emergency department.
Time Frame: through call completion, an average of 5 minutes
|
Percentage of participants among all calls referred to outpatient and inpatient medicine
|
through call completion, an average of 5 minutes
|
Determine whether the use of video-regulation leads to an increase in call time with the regulating doctor
Time Frame: through call completion, an average of 5 minutes
|
Call time spent with the regulating physician
|
through call completion, an average of 5 minutes
|
Evaluate parents' satisfaction with videoregulation compared with a standard call
Time Frame: 15 days
|
Rating of appellants' satisfaction with the decision on a numerical scale from 1 to 5. 1 being the lowest level of satisfaction and 5 being the highest.
|
15 days
|
Evaluate the number of rescue vectors (fire brigade, private ambulance) triggered but whose decision will ultimately be to "leave on the spot" after the rescue worker's assessment.
Time Frame: through out-of-hospital care completion, an average of 1 hour
|
Number of people left behind after a rescue vehicle has been deployed.
|
through out-of-hospital care completion, an average of 1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC23.0376
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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